Test Details
Methodology
Real-time polymerase chain reaction (PCR) with reflex to enzyme immunoassay (EIA)
Result Turnaround Time
1 - 2 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
Two-step algorithm to aid in the determination of C. difficile infection versus C. difficile colonization
Limitations
This test does not distinguish between viable and nonviable organisms.
Test results are to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures.
This test is for use with unformed (i.e., soft, loose) stool samples only.
This test detects/presumptively differentiates the BI/NAP1/027 strain from other toxigenic strains of C. difficile. Detection of BI/NAP1/027 strains of C. difficile is presumptive and is solely for epidemiological purposes; it is not intended to guide or monitor treatment for C. difficile infections.
The detection of bacterial nucleic acid is dependent on proper specimen collection and handling (including transportation and storage).
Performance characteristics have not been established for patients less than two years of age.
Custom Additional Information
To order this test without reflexing, use Clostridioides difficile Toxin Gene, NAA [183988].
Specimen Requirements
Specimen
Stool (unformed)
Volume
5 g
Minimum Volume
0.5 g or 0.5 mL liquid stool
Container
Sterile screw-cap container or stool transport without preservatives (Para-Pak® white clean vial). "Cool Whip" containers, denture cups or other similar containers often leak or even explode during transport and may be rejected by the laboratory.
Stability Requirements
Temperature | Period |
|---|---|
Refrigerated | 3 days (stability provided by manufacturer or literature reference) |
Storage Instructions
Specimen should be kept at 2°C to 8°C and transported to the laboratory within 24 hours of collection. Do not freeze.
Causes for Rejection
Unlabeled specimen or name discrepancy between specimen and test request label; quantity insufficient; formed stools; frozen stool; stool in preservative; specimens other than stool; improper storage or transport device; grossly leaking specimens; specimen stored at room temperature; or specimen older than 72 hours stored at 2°C to 8°C
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 183992 | C difficile toxin gene NAA,Rfx | 54067-4 | 183990 | C difficile toxin gene NAA | 54067-4 | |
| Order Code | 183992 | |||||
| Order Code Name | C difficile toxin gene NAA,Rfx | |||||
| Order Loinc | 54067-4 | |||||
| Result Code | 183990 | |||||
| Result Code Name | C difficile toxin gene NAA | |||||
| UofM | ||||||
| Result LOINC | 54067-4 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 183993 | Cdiff Toxins A+B,EIA+Clin Info | 183991 | C difficile Toxins A+B, EIA | 34468-9 | |
| Reflex 1 | ||||||
| Order Code | 183993 | |||||
| Order Name | Cdiff Toxins A+B,EIA+Clin Info | |||||
| Result Code | 183991 | |||||
| Result Name | C difficile Toxins A+B, EIA | |||||
| UofM | ||||||
| Result LOINC | 34468-9 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 183993 | Cdiff Toxins A+B,EIA+Clin Info | 183994 | C difficile Clinical Interp | N/A | |
| Reflex 1 | ||||||
| Order Code | 183993 | |||||
| Order Name | Cdiff Toxins A+B,EIA+Clin Info | |||||
| Result Code | 183994 | |||||
| Result Name | C difficile Clinical Interp | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||